Sevelamer carbonate dry suspension for oral administration

Abstract

The invention relates to a sevelamer carbonate dry suspension. The sevelamer carbonate dry suspension comprises 35-55% of a suspending aid, 15-25% of a filler, 5-10% of a binder, 2-5% of dextrin, 2-5% of magnesium stearate, 0.1-1% of sucrose and 0.1-1% of titanium dioxide. The sevelamer carbonate dry suspension can improve action time of sevelamer carbonate in the human body and improve drug compliance.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a sevelamer carbonate composition and a preparation method thereof. Background technique [0002] Hyperphosphatemia is common in patients with end-stage renal disease, and hyperphosphatemia can cause hyperparathyroidism and osteodystrophy. Recent studies have found that hyperphosphatemia can still induce soft tissue and vascular calcification, which is an important factor for the increased mortality and cardiovascular disease in patients with end-stage renal disease. Therefore, effective control of serum phosphorus levels has become an important measure to reduce the mortality and incidence of cardiovascular diseases in patients with end-stage renal disease. At present, the treatment of hyperphosphatemia mainly includes dietary phosphorus restriction, dialysis treatment, application of phosphorus binders and removal of parathyroid glands when necessary. First of all, th...

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Problems solved by technology

The dosage form of commercially available sevelamer carbonate is tablet and dry suspension at present, and these two kinds of dosage forms have advantages and disadvantages respectively, and tablet volume is less, and is convenient to carry, has incomparable advantage as long-term medication, but because this The drug dosage of the product is relatively large (2.4~4.8g / day), and the commercially available tablet specification is 800mg or 400mg. Because the raw material of sevelamer carbonate has poor compressibility, the high proportion of excipients causes the tablet volume to be relatively large. Patients with dysphagia have great troubles with medication; the dry suspension can solve the disadvantages of dysphagia after being dispersed in water

[0010] CN104800165A provides Sevelamer Carbonate Dry Suspension, which has uniform particle distribution, good stability, large distribution area in the gastrointestinal tract, fast absorption, high bioavailability, fast drug onset, and better efficacy than Sevelamer Carbonate Premix, but the suspension is a fast-acting drug, which has poor compliance for patients who take it for a long time

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